Ab­b­Vie preps an FDA pitch of promis­ing PhI­II da­ta for block­buster hope­ful elagolix

Hugh Tay­lor

Ab­b­Vie is rolling out the Phase III da­ta it will de­liv­er to the FDA lat­er this year in search of a block­buster ap­proval for elagolix, a top late-stage prospect in their pipeline aimed at crip­pling bouts of en­dometrio­sis. And the in­ves­ti­ga­tors in the study have put some sol­id da­ta on dis­play at the 13th World Con­gress on En­dometrio­sis in Van­cou­ver this af­ter­noon.

In an ab­stract shared with End­points News ear­li­er in the week, Ab­b­Vie re­port­ed that the drug — an oral go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor an­tag­o­nist — demon­strat­ed some clear, dose-de­pen­dent re­spons­es that eas­i­ly out­paced the place­bo arms in two Phase III tri­als, each with more than 800 women en­rolled in them. Both stud­ies tracked clin­i­cal re­spons­es for dys­men­or­rhea — acute and po­ten­tial­ly dis­abling men­stru­al pain — as well as non­men­stru­al pelvic pain.

Ab­b­Vie got this drug in a $575 mil­lion deal it struck in 2010 with Neu­ro­crine $NBIX, which stands to earn a roy­al­ty pay­out on an ap­proval. Just weeks ago Neu­ro­crine won an ap­proval for In­grez­za (val­be­nazine) for tar­dive dysk­i­ne­sia.

In the first elagolix study the low- and high-dose arms reg­is­tered a clin­i­cal re­sponse of 46.4% and 75.8% com­pared to 19.6% of the place­bo arm for dys­men­or­rhea af­ter three months. The sec­ond study de­liv­ered re­mark­ably sim­i­lar re­sults: 43.4% and 72.4% for the low and high dos­es com­pared to 22.7% for the place­bo arm.

The co-pri­ma­ry end­point of non­men­stru­al pelvic pain al­so pro­duced a sta­tis­ti­cal­ly sig­nif­i­cant re­sponse, though the place­bo re­sponse was marked­ly high­er: 50.4% and 54.5% for the two dos­es in one tri­al; 49.8% and 57.8% for the sec­ond tri­al. The place­bo pa­tients ex­pe­ri­enced a 36.5% re­sponse.

“That’s ex­act­ly what I would have ex­pect­ed,” lead in­ves­ti­ga­tor Hugh Tay­lor tells me. With reg­u­lar men­stru­al pain women are more like­ly to bet­ter gauge the drug’s im­pact, while non­men­tru­al pelvic pain can be more vari­able and there­fore more like­ly to leave it­self open to the kind of place­bo re­sponse that many pain drug stud­ies are sus­cep­ti­ble to.

Tay­lor says he rou­tine­ly treats this ail­ment in his prac­tice and ex­pects that an ap­proval will ush­er in a new stan­dard for treat­ing en­dometrio­sis.

“It’s not well rec­og­nized,” he says, “usu­al treat­ed (ini­tial­ly) with oral con­tra­cep­tives, which of­ten don’t work or on­ly par­tial­ly, with side ef­fects…. Hav­ing new op­tions will bring an uptick in recog­ni­tion.” And with added recog­ni­tion, he adds, you can ex­pect to find more docs us­ing elagolix.

Right now the gen­er­al con­sen­sus in the med­ical com­mu­ni­ty is that about 5% to 10% of women in their re­pro­duc­tive years suf­fer from dis­abling bouts of this ail­ment.

An­oth­er late-stage pro­gram for elagolix has been un­der­way for uter­ine fi­broids, which an­a­lysts be­lieve will like­ly be an­nounced in Q3. The cur­rent study for en­dometrio­sis is be­ing pub­lished in the New Eng­land Jour­nal of Med­i­cine.

Ab­b­Vie has been mov­ing sys­tem­at­i­cal­ly to­ward fil­ing the drugs, de­clar­ing its sec­ond Phase III suc­cess for this drug more than a year ago. A spokesper­son for the com­pa­ny says the fil­ing will come lat­er this year. And some an­a­lysts fol­low­ing the com­pa­ny have tapped it as a drug like­ly to earn more than a bil­lion dol­lars a year, mark­ing it as a sig­nif­i­cant part of Ab­b­Vie’s mul­ti-bil­lion dol­lar ef­fort to pre­pare for a day when Hu­mi­ra will no longer be able to de­liv­er the bulk of its rev­enue.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.